PMA P170018S004
- Device
- LIFEPAK® CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S004
- Product code
- MKJ
- Decision date
- 2019-10-23
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a labeling change to support a different configuration of the LIFEPAK CR2 defibrillator.
Current openFDA PMA Record#
- Device
- LIFEPAK® CR2 Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P170018
- Supplement
- S004
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-10-23
- Decision code
- APPR
- Date received
- 2019-09-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a labeling change to support a different configuration of the LIFEPAK CR2 defibrillator.